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Higher Dilution Sculptra Approved

A new FDA-approved label for Sculptra (injectable poly-L-lactic acid (PLLA)) from Galderma includes higher dilution, the addition of immediate use reconstitution, new injection techniques, and the optional addition of lidocaine. Sculptra is the first and only FDA-approved PLLA facial injectable treatment, used to stimulate the skin’s own collagen production to smooth facial wrinkles, such as smile lines.

The new label approval is based on data from physiochemical studies, as well as results from a randomized, evaluator-blinded, parallel-group, multi-center study evaluating the safety and effectiveness of two different dilutions of Sculptra. In the study, treatment immediately following reconstitution with a higher reconstitution volume (9mL including lidocaine) was well tolerated, caused less pain, and was comparable to that of the reference group (Sculptra 5mL) in reducing wrinkle severity of nasolabial folds (NLF) at Week 48 (n=80) as observed by both Investigator and Blinded Evaluators.

Sculptra is typically administered via three treatments spaced at least three weeks apart, with results appearing gradually. In a clinical study, 100 percent of patients still showed improvement in the appearance of wrinkles up to two years after last treatment according to investigator evaluation.

Galderma will use its Galderma Aesthetic Injector Network (GAIN) training and education platform to educate injectors bout the new label, train on injection technique, and share best practices for incorporating Sculptra into their aesthetic offering.

Allergan Aesthetics Completes Acquisition of Soliton

Allergan Aesthetics, an AbbVie company, completed its acquisition of Soliton, Inc. The addition of Soliton and its technology complements Allergan Aesthetics’ portfolio of non-invasive body contouring treatments to now include the RESONIC device.

This device initially received FDA 510(k) clearance for the short-term improvement in the appearance of cellulite, and that clearance has now been expanded to long-term improvement up to one year. In recent clinical data submitted to the FDA, RESONIC demonstrated significant improvement in the appearance of cellulite and 97.6 percent of participants found there was good improvement in the appearance of cellulite at 52-weeks post-treatment.

Resonic has also received FDA 510(k) clearance for use in conjunction with laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients.

Dermatologist Tackles Misinformation Related to COVID-19 Vaccines and Cosmetic Injectables

A recent Wall Street Journal article suggests that patients must choose between neurotoxin treatments or COVID-19 vaccines. While there have been rare reports of non-life-threatening, transient reactions among patients who had recently received hyaluronic acid fillers and then received the mRNA SARS-CoV-2 vaccines, there is no indication of any reaction between the vaccines and injectable botulinum toxin formulations.

“It’s disappointing that the Wall Street Journal failed to properly distinguish between cosmetic injectable treatments. Botox and fillers, like JuveDerm and Restylane, are totally different products,” says dermatologist Joel L. Cohen, MD. “Now we as dermatologists and plastic surgeons have to work again to set the record straight. Misinformation has a huge ripple effect. And this totally inaccurate WSJ article and headline has led to anxious patient phone calls, canceled appointments, and likely even people who have recently been treated with any facial cosmetic injectable agent to delay their vaccine or booster.”

Dr. Cohen emphasizes that patients should be educated that they need not choose cosmetic injectables or vaccination, as they can safely receive both, according to guidelines from the American Society for Dermatologic Surgery. “The fact is Dysport/Botox/Xeomin/Jeuveau are neuromodulators that work on the injected muscle to minimize contraction. Fillers are an actual product that stays placed under the skin to add or restore volume in the folds, cheeks, lips and hands,” he notes. “Furthermore, the issue of fillers and the rare risk of delayed swelling reactions has been reported a year ago. There is nothing new here. Any vaccine can cause the immune system to transiently rev-up, and rarely sinus infections or teeth cleaning procedures can do the same—this can cause some swelling and/or redness, which is usually for a few days, and if prominent then can be treated with over-the-counter agents (like ibuprofen or antihistamines) or even prescription medications (like prednisone or lisinopril). I have even seen patients with no history of facial cosmetic filler treatments get swelling of their lips for several days after the vaccine or booster as well, a condition called angioedema.”

Patients should always discuss concerns with their board-certified core aesthetic physicians.

Obagi Enters Device Arena with The Skintrinsiq System

Obagi is launching the Skintrinsiq device, its first entry into the complementary skincare device market.

The Skintrinsiq system extracts impurities then infuses Obagi skincare products via treatment protocols customized for individual skincare needs.

“The unique design of the Skintrinsiq device combined with its exclusive availability in the physician-dispensed and spa channels allows physicians and other healthcare practitioners to provide an efficacious treatment for the skin that capitalizes on the science and heritage of Obagi products,” says Jaime Castle, Obagi President and CEO, in a news release.

“We know during the pandemic that skincare products for our physician customers increased in importance to their businesses, with demand from patients reaching unprecedented levels. Skintrinsiq’s value proposition is that the treatment has the ability to draw more patients into a practice to experience Obagi products, which will then lead to increased sales of the products.”

The Skintrinsiq device uses Obagi InfuseIQ Technology to gently lift the upper layers of the skin, opening channels allowing impurities to be extracted and Obagi products to be thoroughly absorbed. When the Skintrinsiq vacuum stops, the channels close so that products are locked in and can continue working after the treatment is over. This sets the Skintrinsiq system apart from other devices, which rely on mechanical resurfacing to prepare the skin for application of products.

Treatment protocols can be tailored for all skin types and skincare goals, including protocols that minimize the look of fine lines and wrinkles or that brighten the skin for a more even complexion.

Skintrinsiq treatments are recommended every two weeks for optimal results. For comprehensive skincare, the Skintrinsiq device also offers simultaneous blue and/or red LED light therapy that can be integrated without additional treatment time.

“The Obagi Skintrinsiq device allows for more rapid and thorough absorption of products into the skin, providing an instant boost to the patient’s skin,” says Illinois-based dermatologist Ashish C. Bhatia, MD, FAAD, an associate professor of clinical dermatology at Northwestern University’s Feinberg School of Medicine in Chicago. “It’s easy for my team to administer, and patients leave seeing a noticeable difference in their skin.”

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